The present invention relates to a diagnostic test kit for the collection and testing of fluid samples for selected antigens or antibodies, more particularly, to such a test kit having a cup-like container and a test card for indicating visually the presence or absence of selected drugs of abuse in fluid samples.
The increased availability and use of drugs of abuse by the general population has caused employers, governmental agencies, sports groups and other organizations to utilize drug screening both as a condition of employment and in order to maintain safety in the work place. Typical drug screening tests are performed for the purpose of quickly identifying on a qualitative basis the presence of drugs in a body fluid which may be urine. A complete analysis of the sample may then be carried out in a laboratory only if the preliminary screening results are positive. More and more such drug screenings are taking place on site or the work place and are generally carried out by testing personnel who are not technically trained, such as laboratory technicians. It is thus important that the drug screening procedure is simple but yet reliable. Further, the test apparatus must be such so as to enable the testing personnel to avoid all contact with the fluid specimen which is being tested.
Various forms of devices have been proposed for the collection and taking of body fluids, such as urine, which have proved to be cumbersome in operation since they involve a number of separate steps. Initially, the sample was collected and several additional steps were then required to transfer the urine sample to an analysis device. This multiple step procedure required the manual handling of the specimen through various devices and the use of such transfer devices inevitably caused spills which may result in contamination to the tester and surroundings. In addition, nontechnical personnel who perform the screening tests on urine samples objected to coming into any kind of contact with the urine sample and even the handling of the sample itself.
Many of the known testing devices were rather complex in that they included a container for the specimen, and, subsequently it was necessary to transfer the specimen or at least a portion thereof to another compartment of the container in order to perform the test. This transfer of the specimen required vigorous shaking of the container or turning the container upside down in order to cause the flow of the specimen into a test compartment. It was therefore necessary to make the containers leak proof under such condition and the result was a complicated and expensive container structure.
Further, the containers incorporated the structure by means of which reagent strips were mounted in a test compartment of the container and which structure also enabled the fluid sample to flow into the test compartment into contact with the reagent strips. Such a mounting of the reagent strips further resulted in complicated the structure of the container since it was also necessary that provision be made to view the reagent strips from outside of the container. This was generally achieved by providing a transparent window or some other mounting of the reagent strips so as to be visible to testing personnel.
It is therefore the principal object of the present invention to provide a novel and improved device for the testing of body fluid samples, particularly urine, for several selected antigens or antibodies at the same time.
It is a further object of the present invention to provide a novel and improved test card having a plurality of immunoassay test strips on one or both sides thereof with each strip being responsive to a selected drug of abuse and having a visual endpoint to indicate the presence or absence of a particular drug.
It is an additional object of the present invention to provide such a device which includes a closable container for retaining a urine sample having such a closure structure that a plurality of test strips may be introduced at the same time into the container to contact the urine sample.
It is another object of the present invention to provide such a device which includes a closable container for retaining a fluid sample having such a height that the visual indication of a selected antigen or antibody is visible above the closure cap when the bottom end of the test card is in contact with the fluid sample within the container.
The objects of the present invention are achieved and the disadvantages of the prior art are eliminated by the diagnostic test device according to the present invention which may comprise a cup-like container for retaining a fluid sample to be tested. The open top of the container has a closure cover or cap and there is a diametrical slit in the cap. The slit is of such a size to accommodate a test card which has a plurality of immunoassay test strips mounted thereon in parallel on one side or both sides and each test strip is responsive to a particular drug of abuse. The test card is insertable through the slit so as to have one end immersed in a contained urine sample to a predetermined depth whereby the visual results of each test strip may be seen through the translucent or transparent wall of the container so as to indicate the presence or absence of a particular drug of abuse in the urine sample. If the sample should test xe2x80x9cpositivexe2x80x9d to indicate the presence of a drug in the urine, it is then necessary to send the sample to a certified laboratory for confirmatory testing. For this purpose, a second closure cap which is solid, i.e., not slit, is provided which may be threaded into the open end of the cup-like container. The test card is removed from the container, the solid closure cap may be threaded on or snapped on to close the container and the container is then ready for shipment to a laboratory.
As described above, the test kit includes a drug abuse test device for collecting and testing a urine sample. This test device comprises a cup-like container having a wall which is substantially transparent or has a degree of translucency and having an open top upon which is threaded a closure cover provided with a slit therein to receive a test card. A solid second closure cap which threads over or snaps on the outer end of the cup-like container is provided to seal the container to permit the safe shipment of a fluid sample therein.
The height of the container may be such that the visual indication of the presence or absence of a selected drug is visible above the closure cap when the bottom end of the test card is in contact with the fluid sample within the container.
The test kit also includes a screen test card for drugs of abuse which may comprise a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips are fastened side by side in parallel on one or both sides of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. The test card thus provides for the simultaneous detection of multiple analytes.